(1)

On 13 September 2013, Monsanto Europe SA/NV submitted an application for the placing on the market of foods, food ingredients and feed containing, consisting of, or produced from MON 87427 × MON 89034 × NK603 maize (‘the application’) to the national competent authority of Belgium in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003. The application also covered the placing on the market of products consisting of or containing genetically modified maize MON 87427 × MON 89034 × NK603 for uses other than food and feed, with the exception of cultivation.

(2)

The application covered, for those uses, all three sub-combinations of the single genetic modification events constituting maize MON 87427 × MON 89034 × NK603. One of those sub-combinations, MON 89034 × NK603, was already authorised under Commission Decision 2010/420/EU (2). Monsanto Europe SA/NV asked the Commission to repeal that Decision when authorising maize MON 87427 × MON 89034 × NK603 and all its sub-combinations.

(3)

In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application included information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC of the European Parliament and of the Council (3) and the information required by Annexes III and IV to that Directive. It also included a monitoring plan for environmental effects set out in Annex VII to Directive 2001/18/EC.

(4)

On 1 August 2017, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (4). EFSA concluded that genetically modified maize MON 87427 × MON 89034 × NK603, as described in the application, is as safe and as nutritious as the non-genetically modified comparator and the tested non-genetically modified reference varieties in the context of the scope of the application. No new safety concerns were identified for the previously assessed sub-combination MON 89034 × NK603 and previous conclusions on this sub-combination remain valid.

(5)

For the remaining two sub-combinations, the EFSA concluded that they are expected to be as safe and as nutritious as the single events MON 87427, MON 89034 and NK603, as the previously assessed sub-combination MON 89034 × NK603 and as the three-event stack maize MON 87427 × MON 89034 × NK603.

(6)

In its opinion, the EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

(7)

The EFSA also concluded that the monitoring plan for environmental effects submitted by the applicant, consisting of a general surveillance plan, is in line with the intended uses of the products. However, the proposed monitoring plan was revised, as recommended by the EFSA, to cover explicitly the sub-combinations.

(8)

Taking into account those considerations, the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 87427 × MON 89034 × NK603 and its three possible sub-combinations for the uses listed in the application should be authorised.

(9)

Decision 2010/420/EU authorising maize MON 89034 × NK603 should be repealed.

(10)

A unique identifier should be assigned to each genetically modified organism (‘GMO’) covered by this Decision in accordance with Commission Regulation (EC) No 65/2004 (5). The unique identifier assigned to maize MON 89034 × NK603 by Decision 2010/420/EU should continue to be used.

(11)

On the basis of the EFSA opinion, no specific labelling requirements, other than those laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council (6), appear to be necessary for the products covered by this Decision. However, in order to ensure the use of those products within the limits of the authorisation granted by this Decision, the labelling of the products containing or consisting of maize MON 87427 × MON 89034 × NK603, MON 87427 × NK603, MON 89034 × NK603 and MON 87427 × MON 89034, with the exception of food products, should be complemented by a clear indication that the products in question are not intended for cultivation.

(12)

The authorisation holder should submit annual reports on the implementation of the activities set out in the monitoring plan for environmental effects and on the results. Those results should be presented in accordance with the standard reporting format requirements laid down in Commission Decision 2009/770/EC (7).

(13)

The EFSA opinion does not justify the imposition of specific conditions for the protection of particular ecosystems/environment and geographical areas, as provided for in Article 6(5)(e) and Article 18(5) of Regulation (EC) No 1829/2003.

(14)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed as provided for in Regulation (EC) No 1829/2003.

(15)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (8).

(16)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it to the appeal committee for further deliberation. The measures provided for in this Decision are in accordance with the opinion of the appeal committee,

(a)

the unique identifier MON-87427-7 × MON-89Ø34-3 × MON-ØØ6Ø3-6 for genetically modified maize (Zea mays L.) MON 87427 × MON 89034 × NK603;

(b)

the unique identifier MON-87427-7 × MON-ØØ6Ø3-6 for genetically modified maize (Zea mays L.) MON 87427 × NK603;

(c)

the unique identifier MON-89Ø34-3 × MON-ØØ6Ø3-6 for genetically modified maize (Zea mays L.) MON 89034 × NK603;

(d)

the unique identifier MON-87427-7 × MON-89Ø34-3 for genetically modified maize (Zea mays L.) MON 87427 × MON 89034.

(a)

foods and food ingredients containing, consisting of, or produced from genetically modified maize referred to in Article 1;

(b)

feed containing, consisting of, or produced from genetically modified maize referred to in Article 1;

(c)

genetically modified maize, referred to in Article 1, in products containing them or consisting of them, for uses other than those provided for in points (a) and (b) of this Article, with the exception of cultivation.